MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH ASP6025

Catalog Number	14049543267
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023 leica biosystems received the confirmation, that the customer experienced suboptimal tissue processing on their asp6025, tissue processor.As a result the tissue was undiagnosable, and a rebiopsy for 9 patients was recommended.
Additional Manufacturer Narrative
An investigation of the incident is currently underway and a follow up will be submitted should additional information become available following the investigation.
Additional Manufacturer Narrative
The investigation revealed the following: the instrument logs were analyzed by the lbs senior quality engineer, and no instrument error was detected during the processing steps that could conceivably be linked to the damaged tissue.The incident was presumably user related due to an application issue (thresholds set up).Test runs have been conducted successfully after the changing all reagents and paraffin.According to the lbs senior quality engineer, the purity of the xylene (s8) and paraffin(i) used may have been insufficient to meet processing requirements, which may have caused the tissues to be under processed.Also, the ethanol concentrations in s1, s2, s3 and s4 significantly exceeded the ifu recommendation.A recommendation was made to the customer to optimize the thresholds for the reagents and the paraffin.

• Brand Name: ASP6025
• Common Device Name: ASP6025
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstrasse 17-19; nussloch, 69226 ; GM 69226
• Manufacturer (Section G): LEICA MICROSYSTEMS LTD. SHANGHAI; building 1, 258 jinzang road; shanghai,pudong, 20120 6; CH 201206
• Manufacturer Contact: robert gropp ; heidelbergerstr. 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 18289924
• Report Number: 8010478-2023-00015
• Device Sequence Number: 6264558
• Product Code: IEO
• UDI-Device Identifier: 04049188158819
• UDI-Public: (01)04049188158819
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 14049543267
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2023
• Supplement Date Received by Manufacturer: 01/13/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 02/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown